Will Late Loss Debate Stifle Device Start-Up Innovation?
This article was originally published in Start Up
Executive SummaryThe failure of Medtronic's Endeavor stent to hit its primary clinical trial endpoint has again spurred debate over surrogate endpoints, a potentially big issue for small companies.
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Steve Niedelman of the law firm King & Spalding gave manufacturers a few words of advice when prepping their so-called front rooms, where US FDA investigators do the majority of their work during facility inspections. See what he said here.